EURneffy positioned to be the first and only needle-free adrenaline option authorized for emergency treatment of allergic reactions (anaphylaxis) in Europe

EURneffy被定位为欧洲第一个也是唯一一个被授权用于紧急治疗过敏反应（过敏反应）的无针肾上腺素选择

Positive CHMP opinion and recommendation for approval of a mixed application for marketing authorization based on comprehensive data package comparing EURneffy to approved injectable products across a range of dosing scenarios as well as supportive historical data from injectable products

CHMP对批准上市授权混合申请的积极意见和建议，基于综合数据包，将EURneffy与批准的注射产品在一系列剂量方案中进行比较，以及注射产品的支持性历史数据

Same data package under review by FDA with a PDUFA date of October 2, 2024

FDA正在审查相同的数据包，PDUFA日期为2024年10月2日

SAN DIEGO, June 28, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to the development of products to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion on the application for marketing authorization for EURneffy® (adrenaline nasal spray) and recommended related market authorization in the European Union (EU) for the emergency treatment of allergic reactions (anaphylaxis).

圣地亚哥，2024年6月28日（环球通讯社）--ARS制药公司（纳斯达克：SPRY）是一家致力于开发产品以更好地保护患者免受可能导致过敏反应的严重过敏反应的生物制药公司，今天宣布，欧洲药品管理局（EMA）人用药品委员会（CHMP）对EURneffy®（肾上腺素鼻喷雾剂）的上市许可申请持积极意见，并建议欧盟（EU）对过敏反应（过敏反应）的紧急治疗进行相关市场授权。

The CHMP positive opinion will now be submitted to the European Commission (EC) for the formal marketing authorization process, which is expected to occur in Q3 2024..

CHMP正面意见现在将提交给欧盟委员会（EC），以进行正式的上市授权流程，预计将于2024年第三季度进行。。

“Today’s announcement marks a major milestone in the treatment of severe allergies and moves us one step closer to bringing EURneffy to patients in the EU as the first and only needle-free adrenaline option for the emergency treatment of allergic reactions, up to anaphylaxis,” said Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma.

ARS Pharma联合创始人、总裁兼首席执行官Richard Lowenthal说：“今天的宣布标志着严重过敏治疗的一个重要里程碑，使我们更接近将EURneffy作为第一个也是唯一一个无针肾上腺素选择，用于紧急治疗过敏反应，直至过敏反应。”。

“EURneffy’s needle-free, smaller form and longer and less temperature-sensitive shelf-life may increase the likelihood that patients will both carry and administer adrenaline, which improves outcome of allergic reactions.”.

“EURneffy的无针、更小的形状以及更长和更少的温度敏感性保质期可能会增加患者携带和服用肾上腺素的可能性，从而改善过敏反应的结果。”。

The positive opinion and recommendation for approval of a mixed application for marketing authorization grounded on Article 8(3) of Directive 2001/83./EC from the CHMP is based on data from one of the most extensive nasal spray development programs in history involving more than 700 study participants and over 1,200 administrations, as well as studies and peer-reviewed literature substituting or supporting certain tests and studies.

根据CHMP指令2001/83/EC第8（3）条，批准上市授权混合申请的积极意见和建议是基于历史上最广泛的鼻喷雾剂开发计划之一的数据，涉及700多名研究参与者和1200多名管理人员，以及替代或支持某些测试和研究的研究和同行评审文献。

The basis of approval for EURneffy in Europe was efficacy supported by surrogate pharmacodynamic endpoints. The pharmacodynamics and pharmacokinetics of 2 mg EURneffy were evaluated across a range of dosing conditions, including single and repeat dosing, self-administration by patients, dosing in pediatrics, and during multiple nasal conditions that can cause congestion and rhinorrhea such as nasal allergen challenge or infectious rhinitis caused by a cold/flu.

。在一系列给药条件下评估了2 mg EURneffy的药效学和药代动力学，包括单次和重复给药，患者自我给药，儿科给药，以及可能导致充血和鼻漏的多种鼻腔疾病，如鼻过敏原挑战或感冒/流感引起的传染性鼻炎。

The EURneffy mixed application under Article 8(3) of Directive 2001/83./EC will benefit from an eight-year period of data protection whereby another applicant cannot rely on support from the EURneffy application, and a ten-year period of marketing protection during which a generic, hybrid or biosimilar cannot be placed on the market.

欧盟指令2001/83/EC第8（3）条规定的欧尔尼菲混合申请将受益于八年的数据保护期，即另一申请人不能依赖欧尔尼菲申请的支持，以及十年的营销保护期，在此期间，仿制药，混合药或生物仿制药不能投放市场。

The issued composition of matter and method of treatment patents covering EURneffy in Europe have an expiration date in 2039..

已发布的涵盖欧洲EURneffy的物质组成和处理方法专利的有效期为2039年。。

Following grant of marketing authorization by the EC expected in Q3 2024, ARS Pharma anticipates that EURneffy will be made available to patients in Europe in Q4 2024 by a pharmaceutical company with an already established commercial footprint in Europe.

在预计2024年第三季度获得欧盟委员会的上市授权后，ARS Pharma预计，2024年第四季度，欧洲已有商业足迹的制药公司将向欧洲患者提供EURneffy。

The same data package reviewed by CHMP that resulted in its positive opinion and approval recommendation was submitted to the U.S. Food and Drug Administration (FDA) on April 2, 2024. FDA acknowledged receipt of the submission and considered it a complete response to the September 19, 2023 action letter with no comments.

CHMP审查的相同数据包于2024年4月2日提交给美国食品和药物管理局（FDA），该数据包产生了积极的意见和批准建议。FDA承认收到了提交的文件，并认为这是对2023年9月19日行动信的完整回应，没有任何评论。

The company’s New Drug Application is under review by FDA, with a neffy® PDUFA action date assigned by the FDA of October 2, 2024..

该公司的新药申请正在接受FDA的审查，FDA指定的neffy®PDUFA行动日期为2024年10月2日。。

EURneffy is the trade name for neffy® (epinephrine nasal spray) in the European Union.

EURneffy是neffy®（肾上腺素鼻喷雾剂）在欧盟的商标名。

About Type I Allergic Reactions including Anaphylaxis

关于I型过敏反应，包括过敏反应

Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only approved medication for these reactions in Europe. While adrenaline autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation.

I型严重过敏反应是严重且可能危及生命的事件，可能在接触过敏原的几分钟内发生，需要立即用肾上腺素治疗，肾上腺素是欧洲唯一批准用于这些反应的药物。虽然肾上腺素自动注射器已被证明非常有效，但有一些众所周知的局限性导致许多患者和护理人员在紧急情况下延迟或不进行治疗。

These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency..

这些限制包括对针头的恐惧，缺乏便携性，与针头相关的安全问题，缺乏可靠性以及设备的复杂性。即使患者或护理人员携带自动注射器，超过一半的人在紧急情况下需要时会延迟或不使用该设备。。

About ARS Pharmaceuticals, Inc.

关于ARS制药公司。

ARS Pharma is a biopharmaceutical company dedicated to the development of products to better protect patients from severe allergic reactions that could lead to anaphylaxis. The Company is developing neffy® (trade name EURneffy in the EU) (previously referred to as ARS-1), an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions including food, medications and insect bites that could lead to life-threatening anaphylaxis.

ARS Pharma是一家生物制药公司，致力于开发产品，以更好地保护患者免受可能导致过敏反应的严重过敏反应。该公司正在开发neffy®（欧盟商品名EURneffy）（以前称为ARS-1），这是一种临床开发中的鼻内肾上腺素产品，用于患有I型过敏反应的患者及其护理人员，包括食物，药物和昆虫叮咬，可能导致危及生命的过敏反应。

For more information, visit www.ars-pharma.com..

有关更多信息，请访问www.ars-pharma.com。。

Forward-Looking Statements

前瞻性声明

Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include but are not limited to: the potential approval of neffy in the EU or U.S.; the expected timing for the EC decision; the PDUFA action date for neffy; the needle-free profile of neffy increasing the likelihood that patients will both carry and administer adrenaline; and other statements that are not historical fact.

本新闻稿中并非纯粹历史性的声明是1995年《私人证券诉讼改革法案》所指的“前瞻性声明”。这些声明包括但不限于：neffy在欧盟或美国的潜在批准。；EC决定的预期时间；内菲的PDUFA行动日期；neffy的无针特征增加了患者携带和服用肾上腺素的可能性；以及其他非历史事实的陈述。

Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “expects,” “potential,” “will,” and similar expressions are intended to identify forward-looking statements.

由于此类报表存在风险和不确定性，因此实际结果可能与此类前瞻性报表明示或暗示的结果存在重大差异。诸如“预期”、“期望”、“潜在”、“将”等词语以及类似的表达方式旨在识别前瞻性陈述。

These forward-looking statements are based upon ARS Pharma’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the positive opinion from CHMP does not guarantee the EC will approve the related marketing authorization; the ability to obtain and maintain regulatory approval for neffy; potential safety and other complications from neffy; the labelling for neffy, if approved; the scope, progress and expansion of developing and commercializing neffy; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharma’s ability to protect its intellectual property position; and the impact of government laws and regulations.

这些前瞻性陈述基于ARS Pharma目前的预期，并涉及可能永远不会实现或可能被证明不正确的假设。由于各种风险和不确定性，实际结果和事件发生的时间可能与此类前瞻性声明中的预期有重大差异，其中包括但不限于CHMP的积极意见并不保证EC会批准相关的营销授权；获得和维持neffy监管批准的能力；neffy的潜在安全性和其他并发症；neffy的标签（如果批准）；开发和商业化neffy的范围、进展和扩展；因此，市场的规模和增长以及其相对于肌肉注射产品的市场接受率和程度；ARS Pharma保护其知识产权地位的能力；以及政府法律法规的影响。

Add.

添加。

ARS Investor Contact:

ARS投资者联系人：

Justin Chakma

贾斯汀·查克马

ARS Pharmaceuticals

ARS制药公司

justinc@ars-pharma.com

justinc@ars-pharma.com

ARS Media Contact:

ARS媒体联系人：

Christy Curran

克里斯蒂·柯兰

Sam Brown Inc.

山姆·布朗公司。

christycurran@sambrown.com

christycurran@sambrown.com